{"id":405531,"date":"2010-03-08T16:51:00","date_gmt":"2010-03-08T21:51:00","guid":{"rendered":"tag:typepad.com,2003:post-6a00d8341c89dd53ef012877a47dee970c"},"modified":"2010-03-08T16:53:20","modified_gmt":"2010-03-08T21:53:20","slug":"recent-report-about-ortho-evra-safety-seems-to-contradict-earlier-findings-from-same-group","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/405531","title":{"rendered":"Recent Report About Ortho Evra Safety Seems To Contradict Earlier Findings From Same Group"},"content":{"rendered":"
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Third\u00a0Boston Collaborative Drug Surveillance Program Study Analysis Concerning Ortho Evra And Blood Clot Side Effect Risk\u00a0Causes Confusion<\/span><\/span><\/span><\/strong><\/p>\n

(Posted by Tom Lamb at DrugInjuryWatch.com<\/strong><\/font><\/span><\/a>)
<\/strong><\/font><\/strong><\/font><\/span><\/span><\/span><\/span><\/span>
Let us start with this relatively\u00a0recent medical journal article, “Postmarketing study of ORTHO EVRA and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism”<\/a>, published in the January 1, 2010 edition of Contraception<\/em>, which reports the findings from a Boston Collaborative Drug Surveillance Program study\u00a0about the Ortho Evra birth control patch.\u00a0 <\/p>\n

From the Abstract<\/a> for this January 2010 article:<\/p>\n

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BACKGROUND: Concern has been raised that the risk of venous thromboembolism (VTE) in users of the ORTHO EVRA patch is higher compared to users of oral contraceptives (OCs). STUDY DESIGN: We identified idiopathic cases of VTE and controls, matched on age and index date, from among women in the United States PharMetrics\/IMS and MarketScan databases who were current users of the patch or levonorgestrel-containing OCs with 30 mcg of ethinyl estradiol….\u00a0 CONCLUSION: These results provide evidence that the risk of idiopathic VTE in users of the patch is not materially different than that of users of levonorgestrel-containing OCs in women aged 39 years or younger. We cannot rule out some increase in the risk in women aged 40 years or older.<\/p>\n<\/blockquote>\n

It seems that the findings presented in this January 2010 article come from a Phase IV Ortho Evra clinical trial known as\u00a0“Relative Risks for Non-Fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-Containing Oral Contraceptives.”<\/a><\/p>\n

From the ClinicalTrials.gov record<\/a>\u00a0for this Ortho Evra safety study (last processed on March 5, 2010 according to site; accessed March 8, 2010):<\/p>\n

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Purpose<\/strong><\/span> <\/p>\n

This study uses the PharMetrics insurance claims database to estimate relative risks for non-fatal venous thromboembolism (including cerebral venous sinus thrombosis), ischemic stroke, and acute myocardial infarction (heart attack), in current users of ORTHO EVRA (norelgestromin and ethinyl estradiol contraceptive patch) compared to current users of oral levonorgestrel-containing oral contraceptives with 30 micrograms ethinyl estradiol, with special attention to duration of use….<\/p>\n

Contacts and Locations<\/strong><\/span> <\/p>\n

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511784<\/p>\n

Sponsors and Collaborators<\/strong> <\/p>\n

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.<\/p>\n

Boston Collaborative Drug Surveillance Program<\/p>\n<\/blockquote>\n

To recap, the bottom line from this January 2010\u00a0report about the latest study analysis\u00a0done by Boston Collaborative Drug Surveillance Program (BCDSP) is that Ortho Evra does not increase the risk of blood clot-related side effects, or venous thromboembolism<\/strong>, any more than birth control pills that contain levonorgestrel and 30 micrograms ethinyl estradiol, with the possible exception of women over 40 years of age.<\/p>\n

Now let us go back in time to see what J&J and BCDPS have said previously\u00a0about\u00a0a woman’s\u00a0risk of developing blood clot-related side effects such as pulmonary embolism (PE) and deep vein thrombosis (DVT) as well as heart attack and stroke while using the Ortho Evra patch.<\/p>\n

In September 2006 J&J revised the Package Insert for Ortho Evra to include for the first time a warning about the increased risk of venous thromboembolism.\u00a0 This new label, however, included conflicting information about that risk by mentioning two different study results concerning clotting risk.<\/p>\n

According to this new September 2006 label, one study showed that patch users were twice as likely as birth control pill users to develop venous thromboembolism.\u00a0 The other study showed that patch users and pill users were equally likely to develop venous thromboembolism. <\/p>\n

The results from a later study that was done for J&J by the Boston Collaborative Drug Surveillance Program (BCDSP) regarding the safety of Ortho Evra — the second such study done for J&J by BCDSP, to be precise — became available in or about August 2007.\u00a0 In relevant part, this particular BCDSP study showed that the odds of developing venous thromboembolism were, in fact, higher for women aged 15 \u2013 44 who use the Ortho Evra patch than women using birth control pills<\/strong>.\u00a0 In January 2008 the FDA ordered J&J to put the results of this second BCDSP study on the Ortho Evra patch label<\/a>.<\/p>\n

So does this\u00a0January 2010\u00a0medical journal\u00a0report about the latest Ortho Evra\u00a0study done by BCDSP for J&J — seemingly their third study — serve to refute the key finding\u00a0from the second study, namely that the odds of developing venous thromboembolism were higher for women who are\u00a015 to 44 year old?<\/p>\n

Any guidance or insight would be most appreciated.<\/p>\n

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DrugInjuryLaw.com<\/font><\/span><\/strong><\/a>: Legal Information And News About Prescription Drug Side Effects<\/strong><\/span><\/span><\/span><\/span><\/p>\n